Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name System, Surgical, Computer Controlled Instrument
510(k) Number K250786
Device Name SP Endoscope, 0° (430600)
Applicant
Intuitive Surgical, Inc.
1266 Kifer Rd.
Suunyvale,  CA  94086
Applicant Contact Kunal Gunjal
Correspondent
Intuitive Surgical, Inc.
1266 Kifer Rd.
Suunyvale,  CA  94086
Correspondent Contact Kunal Gunjal
Regulation Number876.1500
Classification Product Code
NAY  
Date Received03/14/2025
Decision Date 05/13/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-